Online presentation: Work-sharing, reliance, and other novel approaches to accelerating review, approvals, and access
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These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.
Presentation
- Presented by: Michael Shum
- Presented at: RAPS Convergence 2020
- Presentation date: 25 November 2020
- Presentation summary: This presentation provides an overview of TGA's comparable overseas regulator pathways and international work-sharing activities for prescription medicines. It was delivered in a joint session with representatives from the US Food and Drug Administration and Health Canada.
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